Zdrowie i gospodarka · 26/11/2003

FDA Releases Final Guidance on Bundling Multiple Medical Devices or Indications in a Single Submission

The Food and Drug Administration (FDA) has released a final guidance on bundling multiple medical devices or indications in a single premarket submission, effective immediately. This policy is part of the Medical Device User Fee and Modernization Act of 2002 and aims to streamline the submission process while meeting performance goals.